System and method for microdose injection

ABSTRACT

A system for injecting includes a syringe body, a syringe interior, a syringe flange, and a stopper member and an injectable fluid disposed in the syringe interior. The system also includes a plunger member coupled to the stopper member. The system further includes a finger flange removably coupled to the syringe flange, the finger flange defining a pair of side openings and a pair of bumps adjacent respective side openings. Moreover, the system also includes a swing spacer rotatably coupled to the finger flange, the swing spacer defining a pair of arms, a pair of pivot pins, two pairs of slots, and a pair of indentations. The swing spacer is configured to define a distance of movement of the plunger member relative to the syringe body along a longitudinal axis of the syringe body, thereby defining a dose of the injectable fluid.

The present application claims priority to U.S. Provisional PatentApplication Ser. No. 63/040,384, filed on Jun. 17, 2020 entitled “SYSTEMAND METHOD FOR MICRODOSE INJECTION.” This application includes subjectmatter similar to the subject matter described in the following co-ownedU.S. patent applications: (1) U.S. Utility patent application Ser. No.16/683,126, filed on Nov. 13, 2019, and entitled “SYSTEM AND METHOD FORMICRODOSE INJECTION”; (2) Ser. No. 14/696,342, filed Apr. 24, 2015, andentitled “SYSTEM AND METHOD FOR SAFETY SYRINGE”; (3) Ser. No.14/543,787, filed Nov. 17, 2014, and entitled “SYSTEM AND METHOD FORDRUG DELIVERY WITH A SAFETY SYRINGE”; (4) Ser. No. 14/321,706, filedJul. 1, 2014, and entitled “SAFETY SYRINGE”; and (5) Ser. No.62/416,102, filed Nov. 1, 2016, and entitled “SYSTEM AND METHOD FORSAFETY SYRINGE”; (6) Ser. No. 62/431,382, filed Dec. 7, 2016, andentitled “SYSTEM AND METHOD FOR SAFETY SYRINGE”; (7) Ser. No.62/480,276, filed Mar. 31, 2017, and entitled “SYSTEM AND METHOD FORSAFETY SYRINGE; (8) Ser. No. 62/508,508, filed May 19, 2017, andentitled “SYSTEM AND METHOD FOR COLLECTING INJECTION INFORMATION”; (9)Ser. No. 62/542,230, filed Aug. 7, 2017, and entitled “CARTRIDGE SAFETYINJECTION SYSTEM AND METHODS”; (10) Ser. No. 15/801,239, filed Nov. 1,2017, and entitled “SYSTEM AND METHOD FOR SAFETY SYRINGE”; (11) Ser. No.15/801,259, filed Nov. 1, 2017, and entitled “SYSTEM AND METHOD FORSAFETY SYRINGE”; (12) Ser. No. 15/801,281, filed Nov. 1, 2017, andentitled “CARTRIDGE SAFETY INJECTION SYSTEM AND METHODS”; (13) Ser. No.15/801,304, filed Nov. 1, 2017, and entitled “SYSTEM AND METHOD FORSAFETY SYRINGE”; (14) Ser. No. 16/011,453, filed Jun. 18, 2018, andentitled “SYSTEM AND METHOD FOR SAFETY SYRINGE”; (15) Ser. No.15/985,354, filed May 21, 2018, and entitled “SYSTEM AND METHOD FORCOLLECTING INJECTION INFORMATION”; and “(16) Ser. No. 16/683,157, filedNov. 13, 2019, and entitled “SYSTEM AND METHOD FOR MULTIPLE SITEINJECTION.” The contents of the applications identified herein are fullyincorporated herein by reference as though set forth in full.

FIELD OF THE INVENTION

The present invention relates generally to injection systems, devices,and processes for facilitating various levels of control over fluidinfusion, and more particularly to systems and methods related tosyringes for delivery microliter range doses of fluids in healthcareenvironments.

BACKGROUND

Millions of syringes, such as that depicted in FIG. 1A 2, are consumedin healthcare environments every day. A typical syringe 2 includes atubular body 4, a plunger 6, and an injection needle 8. As shown in FIG.1B, such a syringe 2 may be utilized not only to inject fluid into apatient, but also to withdraw or expel fluid out of or into a containersuch as a medicine bottle, vial, bag, or other drug containment system10. Indeed, due to regulatory constraints in some countries such as theUnited States as well as sterility maintenance concerns, upon use of amedicine bottle 10 with a syringe 2 as shown in a particular patient'senvironment, such medicine bottle may only be utilized with a singlepatient and then must be disposed of—causing significant medical wastefrom bottle and remaining medicine disposal, and even contributing toperiodic shortages of certain critical drugs.

Referring to FIG. 2A, three Luer-type syringes 12 are depicted, eachhaving a Luer fitting geometry 14 disposed distally, so that they may becoupled with other devices having similar mating geometry, such as theLuer manifold assembly 16 depicted in FIG. 2B. The Luer manifoldassembly of FIG. 2B may be used to administer liquid drugs to thepatient intravenously with or without the use of an intravenous infusionbag. The Luer fittings 14 of the syringes of FIG. 2A may be termed the“male” Luer fittings, while those of FIG. 2B 18 may be termed the“female” Luer fittings; one of the Luer interfaces may be threaded (inwhich case the configuration may be referred to as a “Luer lock”configuration) so that the two sides may be coupled by relativerotation, which may be combined with compressive loading. In otherwords, in one Luer lock embodiment, rotation, possibly along withcompression, may be utilized to engage threads within the male fitting14 which are configured to engage a flange on the female fitting 18 andbring the devices together into a fluid-sealed coupling. In anotherembodiment, tapered interfacing geometries may be utilized to providefor a Luer engagement using compression without threads or rotation(such a configuration may be referred to as a “slip-on” or “conical”Luer configuration). While such Luer couplings are perceived to berelatively safe for operators, there is risk of medicinespilling/leaking and parts breakage during the loading to provide a Luercoupling. The use of needle injection configurations, on the other hand,carries with it the risk of a sharp needle contacting or poking a personor structure that is not desired. For this reason, so called “safetysyringes” have been developed.

One embodiment of a safety syringe 20 is shown in FIG. 3 , wherein atubular shield member 22 is spring biased to cover the needle 8 whenreleased from a locked position relative to the syringe body 4. Anotherembodiment of a safety syringe 24 is shown in FIGS. 4A-4B. With such aconfiguration, after full insertion of the plunger 6 relative to thesyringe body 4, the retractable needle 26 is configured to retract 28,26 back to a safe position within the tubular body 4, as shown in FIG.4B. Such a configuration which is configured to collapse upon itself maybe associated with blood spatter/aerosolization problems, the safestorage of pre-loaded energy which may possible malfunction and activatebefore desirable, loss of accuracy in giving full-dose injections due toresidual dead space within the spring compression volume, and/or loss ofretraction velocity control which may be associated with pain andpatient anxiety.

Further complicating the syringe marketplace is an increasing demand forpre-filled syringe assemblies such as those depicted in FIGS. 5A and 5B,which generally include a syringe body, or “drug enclosure containmentdelivery system”, 34, a plunger tip, plug, or stopper 36, and a distalseal or cap 35 which may be fitted over a Luer type interface (FIG. 5Ashows the cap 35 in place; FIG. 5B has the cap removed to illustrate theLuer interface 14. Liquid medicine may reside in the volume, or medicinereservoir, 40 between the distal seal 35 and the distal end 37 of thestopper member 36. The stopper member 36 may include a standard butylrubber material and may be coated, such as with a biocompatiblelubricious coating (e.g., polytetrafluoroethylene (“PTFE”)), tofacilitate preferred sealing and relative motion characteristics againstthe associated syringe body 34 structure and material. The proximal endof the syringe body 34 in FIG. 5B includes a conventional integralsyringe flange 38), which is formed integral to the material of thesyringe body 34. The flange 38 is configured to extend radially from thesyringe body 34 and may be configured to be a full circumference, or apartial circumference around the syringe body 34. A partial flange isknown as a “clipped flange” while the other is known as a “full flange.”The flange is used to grasp the syringe with the fingers to providesupport for pushing on the plunger to give the injection. The syringebody 34 preferably includes a translucent material such as a glass orpolymer. To form a contained volume within the medicine chamber orreservoir 40, and to assist with expulsion of the associated fluidthrough the needle, a stopper member 36 may be positioned within thesyringe body 34. The syringe body may define a substantially cylindricalshape (i.e., so that a plunger tip 36 having a circular cross sectionalshape may establish a seal against the syringe body), or be configuredto have other cross sectional shapes, such as an ellipse.

Such assemblies are desirable because they may be standardized andproduced with precision in volume by the few manufacturers in the worldwho can afford to meet all of the continually changing regulations ofthe world for filling, packaging, and medicine/drug interfacingmaterials selection and component use. Such simple configurations,however, generally will not meet the new world standards for single-use,safety, auto-disabling, and anti-needle-stick. Thus certain suppliershave moved to more “vertical” solutions, such as that 41 featured inFIG. 5C, which attempts to meet all of the standards, or at least aportion thereof, with one solution; as a result of trying to meet thesestandards for many different scenarios, such products may havesignificant limitations (including some of those described above inreference to FIGS. 3-4B) and relatively high inventory and utilizationexpenses.

Moreover, injection systems have reduced accuracy and precision as thevolume of injectable fluid is reduced into the microliter range(“microdose”). In particular, removing air from the syringe body(“de-bubbling”) before injection is difficult to perform accurately andprecisely for such microdose injection systems.

There is a need for injection systems which address shortcomings ofcurrently-available configurations. In particular, there is a need forinjection systems that perform (de-bubble and inject) accurately in themicroliter range. It is also desirable that such syringe assemblies mayutilize the existing and relatively well-controlled supply chain ofconventionally delivered pre-filled cartridges and other off-the-shelfcomponents, and the corresponding assembly machinery and personnel.

SUMMARY

Embodiments are directed to injection systems. In particular, theembodiments are directed to microliter range injection systems thatinclude at least some off-the-shelf syringe components.

In one embodiment, a system for injecting includes a syringe body havingproximal and distal ends, a syringe interior, and a syringe flange atthe proximal end thereof. The system also includes an injectable fluiddisposed in the syringe interior. The system further includes a stoppermember disposed in the syringe interior. Moreover, the system includes aplunger member coupled to the stopper member. In addition, the systemincludes a finger flange removably coupled to the syringe flange, thefinger flange defining a pair of side openings and a pair of bumpsadjacent respective side openings. The system also includes a swingspacer rotatably coupled to the finger flange, the swing spacer defininga pair of arms, a pair of pivot pins, two pairs of slots, and a pair ofindentations. The swing spacer is configured to define a distance ofmovement of the plunger member relative to the syringe body along alongitudinal axis of the syringe body, thereby defining a dose of theinjectable fluid.

In one or more embodiments, the pair of pivot pins on the swing spacerare disposed in the pair of side openings on the finger flange, suchthat the pair of side openings and the pair of pivot pins define a hingeabout which the swing spacer rotates relative to the finger flange.Respective clearances between the pair of pivot pins and respective onesof the pair of side openings allow for axial movement of the swingspacer during priming of the system. The syringe body may also include adistal needle interface configured to be coupled to a needle assemblyhaving a needle.

In one or more embodiments, the swing spacer has an alignedconfiguration wherein a longitudinal axis of the swing spacer is alignedwith the longitudinal axis of the syringe body, and an askewconfiguration the longitudinal axis of the swing spacer is askew fromthe longitudinal axis of the syringe body. The swing spacer in thealigned configuration may limit distal movement of the plunger memberrelative to the syringe body. The swing spacer in the askewconfiguration may not limit distal movement of the plunger memberrelative to the syringe body, such that the swing spacer is configuredto define a distance of movement of the plunger member relative to thesyringe body along a longitudinal axis of the syringe body, therebydefining a dose of the injectable fluid.

In one or more embodiments, the two pairs of slots on the swing spacerinclude two aligned slots and two askew slots. The aligned slots areconfigured to interfere with the pair of bumps on the finger flange toremovably retain the swing spacer in the aligned configuration. Theaskew slots are configured to interfere with the pair of bumps on thefinger flange to removably retain the swing spacer in the askewconfiguration. The pair of indentations on the swing spacer may beconfigured to facilitate user manipulation of the swing spacer to movethe swing spacer between the aligned and askew configurations

In one or more embodiments, the swing spacer also includes a proximalsurface when the swing spacer is in the aligned configuration. Theplunger member may include a stop configured to interfere with theproximal surface on the swing spacer in the aligned configuration tolimit distal movement of the plunger member relative to the syringebody.

In one or more embodiments, wherein the system has a transportconfiguration in which the swing spacer is in the aligned configurationand the stop on the plunger member is disposed a distance proximal ofthe proximal surface of the swing spacer. The system also has a primedconfiguration in which the swing spacer is in the aligned configurationand the stop on the plunger member is in contact with the proximalsurface of the swing spacer. The system further has an injectionconfiguration in which the swing spacer is in the askew configurationand the stop on the plunger member is disposed a distance proximal ofwith a proximal surface of the finger flange. Moreover, the system has acompleted configuration in which the swing spacer is in the askewconfiguration and the stop on the plunger member is in contact with theproximal surface of the finger flange.

In another embodiment, a method for injecting a fluid includes providinga syringe assembly. The syringe assembly includes a syringe body havingproximal and distal ends, a syringe interior, a distal needle interfaceat the distal end thereof, and a syringe flange at the proximal endthereof. The syringe assembly also includes an injectable fluid disposedin the syringe interior. The syringe assembly further includes a stoppermember disposed in the syringe interior. Moreover, the syringe assemblyincludes a plunger member coupled to the stopper member. In addition,the syringe assembly includes a finger flange removably coupled to thesyringe flange, the finger flange defining a pair of side openings and apair of bumps adjacent respective side openings. The syringe assemblyalso includes a swing spacer rotatably coupled to the finger flange, theswing spacer defining a pair of arms, a pair of pivot pins, two pairs ofslots, and a pair of indentations, the swing spacer being in an alignedconfiguration wherein a longitudinal axis of the swing spacer is alignedwith a longitudinal axis of the syringe body. The method also includesmoving the swing spacer from the aligned configuration to an askewconfiguration the longitudinal axis of the swing spacer is askew fromthe longitudinal axis of the syringe body. The method further includesapplying a distally directed force to a proximal end of the plungermember to expel a portion of the injectable fluid from the syringeinterior through the distal needle interface.

In one or more embodiments, wherein the system has a transportconfiguration in which the swing spacer is in the aligned configurationand the stop on the plunger member is disposed a distance proximal of aproximal surface of the swing spacer. The system also has a primedconfiguration in which the swing spacer is in the aligned configurationand the stop on the plunger member is in contact with the proximalsurface of the swing spacer. The system further has an injectionconfiguration in which the swing spacer is in the askew configurationand the stop on the plunger member is disposed a distance proximal ofwith a proximal surface of the finger flange. Moreover, the system has acompleted configuration in which the swing spacer is in the askewconfiguration and the stop on the plunger member is in contact with theproximal surface of the finger flange.

In one or more embodiments, the syringe assembly is provided in thetransport configuration. The method also includes positioning thesyringe assembly in the transport configuration in an uprightorientation before moving the swing spacer from the alignedconfiguration to the askew configuration. The method further includesapplying a distally directed force to the proximal end of the plungermember to expel a gas from the syringe interior through the distalneedle interface to transform the syringe assembly from the transportconfiguration to the primed configuration before moving the swing spacerfrom the aligned configuration to the askew configuration. Moving theswing spacer from the aligned configuration to the askew configurationtransforms the syringe assembly from the primed configuration to theinjection configuration. Applying the distally directed force to theproximal end of the plunger member to expel the portion of theinjectable fluid from the syringe interior through the distal needleinterface transforms the syringe assembly from the injectionconfiguration to the completed configuration.

In one or more embodiments, the swing spacer in the alignedconfiguration limits distal movement of the plunger member relative tothe syringe body. The swing spacer in the askew configuration does notlimit distal movement of the plunger member relative to the syringebody, such that the swing spacer is configured to define a distance ofmovement of the plunger member relative to the syringe body along thelongitudinal axis of the syringe body, thereby defining a dose of theinjectable fluid.

In one or more embodiments, the two pairs of slots on the swing spacerinclude two aligned slots and two askew slots. The aligned slots areconfigured to interfere with the pair of bumps on the finger flange toremovably retain the swing spacer in the aligned configuration. Theaskew slots are configured to interfere with the pair of bumps on thefinger flange to removably retain the swing spacer in the askewconfiguration. Moving the swing spacer from the aligned configuration tothe askew configuration may include grasping the pair of indentations onthe swing spacer.

The aforementioned and other embodiments of the invention are describedin the Detailed Description which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other aspects of embodiments are described in furtherdetail with reference to the accompanying drawings, in which the sameelements in different figures are referred to by common referencenumerals, wherein:

FIGS. 1A-5C illustrate various aspects of conventional injection syringeconfigurations.

FIGS. 6 and 7 are perspective and exploded views of a microdoseinjection system according to some embodiments.

FIG. 8 is a perspective view of a finger flange for use with microdoseinjection systems according to some embodiments.

FIG. 9 is a perspective view of a swing spacer for use with microdoseinjection systems according to some embodiments.

FIGS. 10 to 13 are side views of a microdose injection system in variousconfigurations illustrating microdose injection methods according tosome embodiments.

FIGS. 14 and 15 are side views of a microdose injection system andvarious configurations microdose injection methods according to someembodiments.

In order to better appreciate how to obtain the above-recited and otheradvantages and objects of various embodiments, a more detaileddescription of embodiments is provided with reference to theaccompanying drawings. It should be noted that the drawings are notdrawn to scale and that elements of similar structures or functions arerepresented by like reference numerals throughout. It will be understoodthat these drawings depict only certain illustrated embodiments and arenot therefore to be considered limiting of scope of embodiments.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS Exemplary MicrodoseInjection Systems

FIGS. 6-13 depict a microdose injection system 300 according to anotherembodiment. As used herein, the term “microdose” or “micro-dose”includes, but is not limited to, injections in the 1-1,000 microliterrange. The microdose injection system 300 addresses the problem ofinjections in the microliter (e.g., 10 μL) volume range, which aredifficult to accomplish with a standard injection system whilemaintaining precision (e.g., repeatability) and accuracy (e.g.,proximity to desired volume). The microdose injection system 300utilizes a rotatable swing spacer 360 and a fixed plunger member traveldistance/gap to perform microdose injections.

Like many of the injection systems described in co-owned U.S. patentapplication Ser. Nos. 14/696,342, 14/543,787, 14/321,706, 62/416,102,62/431,382, 62/480,276, 62/508,508, 62/542,230, 15/801,239, 15/801,259,15/801,281, 15/801,304, 16/011,453, 16/683,126, and 16/683,157, thecontents of which were previously fully incorporated herein by referenceas though set forth in full, the microdose injection system 300 utilizesoff-the-shelf syringe bodies 310, stopper members 320, and distal needleinterfaces 330. The microdose injection system 300 may also be used withoff-the-shelf needle assemblies 390 including needle hubs 391 andneedles 392. The finger flange 340 in the microdose injection system 300includes a pair of side openings 342 configured to mate with a pair ofpivot pins 362 on a swing spacer 360, as shown in FIGS. 7, 8, and 9 .

The microdose injection system 300 includes a syringe body 310, astopper member 320, a distal needle interface 330, a finger flange 340,a plunger member 350, a needle assembly 390, and a swing spacer 360.Many of these system components (e.g., the syringe body 310, the stoppermember 320, and the distal needle interface 330) may be off-the-shelfcomponents to utilize the existing and relatively well-controlled supplychain, and the corresponding assembly machinery and personnel. Thestopper member 320 may have a hollow interior with an internal surface,which may have internal threads or may be un-threaded. The plungermember 350 is configured to have a distal end 351, and a stop 352. Theplunger member 350 may be configured to include a stopper interfaceprojection 353, for interface with the stopper member 320.Alternatively, the distal end of the plunger member may be smooth. Thesyringe body 310 may be an off-the-shelf 0.50 cc syringe body 310 toimprove the accuracy of the microdose injection system 300. The needleassembly 390 may be a commercially available, off-the-shelf needleassembly with a needle 392 (e.g., 20-34 gauge and length 6 mm-⅝″; inparticular 32 gauge x 6 mm length). The needle assembly 390 may utilizeLuer lock or Luer slip configurations to attach the needle assembly 390to the syringe body 310/distal needle interface 330. In someembodiments, microdose injection systems 300 can achieve error rates ofless than ±10 μL.

As shown in FIG. 8 , the finger flange 340 includes a pair of sideopenings 342 and a pair of bumps 344 disposed adjacent to and proximalof corresponding ones of the pair side openings 342. The finger flange340 also includes a proximal surface 346 configured to limit distalmovement of the larger member 350 relative to the finger flange 340 andthe syringe body 310 to which the finger flange 340 is coupled. Thefinger flange further includes an internal passage 347 configured toallow the plunger member distal end 351 to be inserted therethrough. Theinternal passage 347 is sized to be smaller than the stop 352 to preventpassage of the stop 352 through the internal passage 347. The fingerflange also includes a syringe interface 348 for coupling to theproximal end of the syringe body 310.

As shown in FIG. 9 , the swing spacer 360 includes a pair of arms 361.The swing spacer 360 also includes a pair of pivot pins 362 configuredto be rotatably disposed in respective ones of the pair of side openings342 in the finger flange such that the pair of pivot pins 362 and thecorresponding pair of side openings 342 define a hinge about which theswing spacer 360 rotates relative to the finger flange 340. The diameterof the pivot pin 362 is sized to be smaller than the diameter of theside openings 342 to allow for axial movement of the swing spacer 360such that during priming of the system 300, the plunger member 350contacts the proximal surface 370 of the swing spacer 360, forcing theswing spacer 360 distally until the distally facing surface 369 of theswing spacer 360 contacts the proximal surface 346 of the finger flange340. The distance between the proximal 370 and distal 369 surfaces ofthe swing spacer define distance 356 (see FIG. 9 ), which is the size ofthe dose of injectable fluid to be delivered. Distance 356 is also thedistance between the proximal surface 370 of the swing spacer 360 andthe proximal surface 346 of the finger flange 340 (see FIG. 12 ). Theswing spacer 360 also includes respective pairs of aligned slots 364 andaskew slots 366 configured to interfere with the pair of bumps 344 onthe finger flange 342 removably retain the swing spacer in respectivealigned and askew configurations as described herein. The swing spacer360 further includes a proximal surface 370 configured to limit distalmovement of the plunger member 350 relative to the finger flange 340 andthe syringe body 310 to which the finger flange 340 is coupled when theswing spacer 360 is in the aligned configuration as described herein.The swing spacer 360 further includes a lateral slot 371 which is sizedto allow the plunger member 350 distal end 351 to be inserted freely andis smaller than the stop 352 to prevent further insertion of the plungermember 350. The lateral slot 371 is further sized to allow rotation ofthe swing spacer 360 into an askew configuration whereby the plungermember 350 is allowed to move distally until the stop 352 contacts theproximal surface 346 of the finger flange 340. The swing spacer 360includes a pair of indentations/finger grip surfaces 368 disposed whereit is accessible to the user's fingers for applying a force to rotatethe swing spacer 360 from the aligned to the askew configuration.

FIG. 10 depicts the microdose injection system 300 in a transportconfiguration in which the microdose injection system 300 is deliveredto a user in a packaging. In some embodiments, the microdose injectionsystem 300 in the transport configuration also includes a needle cover(not shown). FIG. 10 also shows the swing spacer 360 in the alignedconfiguration in which a longitudinal axis of the swing spacer 360 isaligned with a longitudinal axis of the syringe body 310. With the swingspacer 360 and the aligned configuration, the proximal surface 370 ofthe swing spacer 360 interferes with a stop 352 on the plunger member350 to limit distal movement of the plunger member 350 relative to thesyringe body 310. In the transport configuration, the plunger member 350is positioned such that the stop 352 is disposed a distance 354 proximalof the proximal surface 370 of the swing spacer 360. This distance 354is provided to allow the plunger member 350 to be advanced distallyrelative to the syringe body 310 to de-bubble/prime the microdoseinjection system 300 prior to injection. De-bubbling/priming the system300 may include expelling air from the interior of the needle 392,and/or the needle hub 391, and/or the syringe body 310.

FIG. 11 depicts the microdose injection system 300 in a primedconfiguration. The microdose injection system 300 is transformed fromthe transport configuration shown in FIG. 10 to the primed configurationshown in FIG. 11 by first positioning the microdose injection system 380upright/vertical orientation to move the gases/bubbles in the syringebody 310 distally near the distal needle interface 330, then applying adistally directed force to the plunger member 350 to move the plungermember 350 distally until the stop 352 on the plunger member 350 is incontact with the proximal surface 370 of the swing spacer 360. The stop352 on the plunger member 350 is configured such that closing thedistance 354 between the stop 352 and the proximal and 370 of the swingspacer 360 removes all of the gases/bubbles from the syringe body 310and/or the needle assembly 390. The distance 354 can be tuned bymodifying the positions of the plunger member at 350 and the stop 352 inthe transport configuration to control the amount of gases/bubbles to beremoved during de-bubbling.

FIG. 12 depicts the microdose injection system 300 in an injectionconfiguration. The microdose injection system 300 is transformed fromthe primed configuration shown in FIG. 11 to the injection configurationshown in FIG. 12 by moving the swing spacer 360 from the alignedconfiguration shown in FIG. 11 to the askew configuration shown in FIG.12 . In the askew configuration, the longitudinal axis of the swingspacer 360 is askew (e.g., about 60°) from the longitudinal axis of thesyringe body 310. As shown in FIG. 12 , the swing spacer 360 and theaskew configuration does not interfere with distal movement of theplunger member 350 relative to the syringe body 310. Moving the swingspacer 360 from the aligned configuration to the askew configurationuncovers a distance 356 between the stop 352 on the plunger member 350and the proximal surface 346 of the finger flange 340. The distancebetween the proximal 370 and distal 369 surfaces of the swing spacerdefine the plunger rod distance 356 (see FIGS. 9 and 12 ), which is thesize of the dose of injectable fluid to be delivered by the microdoseinjection system 300. In the embodiment depicted in FIGS. 6 to 13 , thedose of injectable fluid may be 50 μL. In other embodiments, the dosemay be 20 to 500 μL.

FIG. 13 depicts the microdose injection system 300 in a completedconfiguration. The microdose injection system 300 is transformed fromthe injection configuration shown in FIG. 12 to the completedconfiguration shown in FIG. 13 by first positioning a tip of the needle392 coupled to the distal needle interface 330 in the injection targeted(e.g., patient), then applying a distally directed force to the plungermember 350 to move the plunger member 350 distally until the stop 352 onthe plunger member 350 is in contact with the proximal surface 346 ofthe finger flange 340. The stop 352 on the plunger member 350 and theswing spacer 360 are configured such that closing the distance 356between the stop 352 and the proximal surface 346 of the finger flange340 delivers a predefined dose of injectable fluid from the syringe body310. The distance 356 can be tuned by modifying the modifying thepositions of the plunger member at 350 and the stop 352 and the size ofthe swing spacer 360 to control the size of the dose of injectablefluid.

After injection, a needle 392 attached to the distal needle interface330 may be retracted such that the sharp tip thereof is contained withinthe needle assembly 390 to provide a safe microdose injection system.Examples of such safe injection systems are described in U.S. patentapplication Ser. No. 14/696,342, the contents of which have beenpreviously Incorporated by reference herein.

FIGS. 14 and 15 depict a microdose injection system 400 in the primedand injection configurations according to some other embodiments. Theswing spacer 460 in the microdose injection system 400 is longer thanthe swing spacer 360 and the microdose injection system 300 depicted inFIGS. 6 to 13 . The distance 456 between the proximal and distalsurfaces of the swing spacer 460 is greater than the distance 356depicted in FIGS. 9 and 12 . Accordingly, the microdose injection system400 is configured to deliver a larger (e.g., 165 μL) dose of aninjectable fluid.

While various embodiments have been described with specific connectors(e.g., slip and Luer), these embodiments can be used with any knowninjection system connectors. While various embodiments have beendescribed with staked needles and needle connectors, these embodimentscan be used with any known permanently coupled needle or needleconnector system.

Various exemplary embodiments of the invention are described herein.Reference is made to these examples in a non-limiting sense. They areprovided to illustrate more broadly applicable aspects of the invention.Various changes may be made to the invention described and equivalentsmay be substituted without departing from the true spirit and scope ofthe invention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processact(s) or step(s) to the objective(s), spirit or scope of the presentinvention. Further, as will be appreciated by those with skill in theart that each of the individual variations described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinventions. All such modifications are intended to be within the scopeof claims associated with this disclosure.

Any of the devices described for carrying out the subject diagnostic orinterventional procedures may be provided in packaged combination foruse in executing such interventions. These supply “kits” may furtherinclude instructions for use and be packaged in sterile trays orcontainers as commonly employed for such purposes.

The invention includes methods that may be performed using the subjectdevices. The methods may comprise the act of providing such a suitabledevice. Such provision may be performed by the end user. In other words,the “providing” act merely requires the end user obtain, access,approach, position, set-up, activate, power-up or otherwise act toprovide the requisite device in the subject method. Methods recitedherein may be carried out in any order of the recited events which islogically possible, as well as in the recited order of events.

Exemplary aspects of the invention, together with details regardingmaterial selection and manufacture have been set forth above. As forother details of the present invention, these may be appreciated inconnection with the above-referenced patents and publications as well asgenerally known or appreciated by those with skill in the art. Forexample, one with skill in the art will appreciate that one or morelubricious coatings (e.g., hydrophilic polymers such aspolyvinylpyrrolidone-based compositions, fluoropolymers such astetrafluoroethylene, PTFE, hydrophilic gel or silicones) may be used inconnection with various portions of the devices, such as relativelylarge interfacial surfaces of movably coupled parts, if desired, forexample, to facilitate low friction manipulation or advancement of suchobjects relative to other portions of the instrumentation or nearbytissue structures. The same may hold true with respect to method-basedaspects of the invention in terms of additional acts as commonly orlogically employed.

In addition, though the invention has been described in reference toseveral examples optionally incorporating various features, theinvention is not to be limited to that which is described or indicatedas contemplated with respect to each variation of the invention. Variouschanges may be made to the invention described and equivalents (whetherrecited herein or not included for the sake of some brevity) may besubstituted without departing from the true spirit and scope of theinvention. In addition, where a range of values is provided, it isunderstood that every intervening value, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention.

Also, it is contemplated that any optional feature of the inventivevariations described may be set forth and claimed independently, or incombination with any one or more of the features described herein.Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin claims associated hereto, the singular forms “a,” “an,” “said,” and“the” include plural referents unless the specifically stated otherwise.In other words, use of the articles allow for “at least one” of thesubject item in the description above as well as claims associated withthis disclosure. It is further noted that such claims may be drafted toexclude any optional element. As such, this statement is intended toserve as antecedent basis for use of such exclusive terminology as“solely,” “only” and the like in connection with the recitation of claimelements, or use of a “negative” limitation.

Without the use of such exclusive terminology, the term “comprising” inclaims associated with this disclosure shall allow for the inclusion ofany additional element—irrespective of whether a given number ofelements are enumerated in such claims, or the addition of a featurecould be regarded as transforming the nature of an element set forth insuch claims. Except as specifically defined herein, all technical andscientific terms used herein are to be given as broad a commonlyunderstood meaning as possible while maintaining claim validity.

The breadth of the present invention is not to be limited to theexamples provided and/or the subject specification, but rather only bythe scope of claim language associated with this disclosure.

What is claimed is:
 1. A system for injecting, comprising: a syringebody having proximal and distal ends, a syringe interior, and a syringeflange at the proximal end thereof; an injectable fluid disposed in thesyringe interior; a stopper member disposed in the syringe interior; aplunger member coupled to the stopper member; a finger flange removablycoupled to the syringe flange, the finger flange defining a pair of sideopenings and a pair of bumps adjacent respective side openings; and aswing spacer rotatably coupled to the finger flange, the swing spacerdefining a pair of arms, a pair of pivot pins, two pairs of slots, and apair of indentations, wherein the swing spacer is configured to define adistance of movement of the plunger member relative to the syringe bodyalong a longitudinal axis of the syringe body, thereby defining a doseof the injectable fluid.
 2. The system of claim 1, wherein the pair ofpivot pins on the swing spacer are disposed in the pair of side openingson the finger flange, such that the pair of side openings and the pairof pivot pins define a hinge about which the swing spacer rotatesrelative to the finger flange.
 3. The system of claim 1, wherein theswing spacer has an aligned configuration wherein a longitudinal axis ofthe swing spacer is aligned with the longitudinal axis of the syringebody, and an askew configuration the longitudinal axis of the swingspacer is askew from the longitudinal axis of the syringe body.
 4. Thesystem of claim 3, wherein the swing spacer in the aligned configurationlimits distal movement of the plunger member relative to the syringebody, and wherein the swing spacer in the askew configuration does notlimit distal movement of the plunger member relative to the syringebody, such that the swing spacer is configured to define the distance ofmovement of the plunger member relative to the syringe body along thelongitudinal axis of the syringe body, thereby defining the dose of theinjectable fluid.
 5. The system of claim 3, wherein the two pairs ofslots on the swing spacer comprises two aligned slots and two askewslots, wherein the aligned slots are configured to interfere with thepair of bumps on the finger flange to removably retain the swing spacerin the aligned configuration, and wherein the askew slots are configuredto interfere with the pair of bumps on the finger flange to removablyretain the swing spacer in the askew configuration.
 6. The system ofclaim 3, wherein the swing spacer further comprises a proximal surfacewhen the swing spacer is in the aligned configuration, and wherein theplunger member comprises a stop configured to interfere with theproximal surface on the swing spacer in the aligned configuration tolimit distal movement of the plunger member relative to the syringebody.
 7. The system of claim 6, wherein the system has: a transportconfiguration in which the swing spacer is in the aligned configurationand the stop on the plunger member is disposed a distance proximal ofthe proximal surface of the swing spacer; a primed configuration inwhich the swing spacer is in the aligned configuration and the stop onthe plunger member is in contact with the proximal surface of the swingspacer; an injection configuration in which the swing spacer is in theaskew configuration and the stop on the plunger member is disposed adistance proximal of with a proximal surface of the finger flange; and acompleted configuration in which the swing spacer is in the askewconfiguration and the stop on the plunger member is in contact with theproximal surface of the finger flange.
 8. The system of claim 3, whereinthe pair of indentations on the swing spacer are configured tofacilitate user manipulation of the swing spacer to move the swingspacer between the aligned and askew configurations.
 9. The system ofclaim 1, wherein the syringe body further comprises a distal needleinterface configured to be coupled to a needle assembly having a needle.10. A method for injecting a fluid, comprising: providing a syringeassembly, the syringe assembly comprising a syringe body having proximaland distal ends, a syringe interior, a distal needle interface at thedistal end thereof, and a syringe flange at the proximal end thereof, aninjectable fluid disposed in the syringe interior, a stopper memberdisposed in the syringe interior, a plunger member coupled to thestopper member, a finger flange removably coupled to the syringe flange,the finger flange defining a pair of side openings and a pair of bumpsadjacent respective side openings, and a swing spacer rotatably coupledto the finger flange, the swing spacer defining a pair of arms, a pairof pivot pins, two pairs of slots, and a pair of indentations, the swingspacer being in an aligned configuration wherein a longitudinal axis ofthe swing spacer is aligned with a longitudinal axis of the syringebody; moving the swing spacer from the aligned configuration to an askewconfiguration wherein the longitudinal axis of the swing spacer is askewfrom the longitudinal axis of the syringe body; applying a distallydirected force to a proximal end of the plunger member to expel aportion of the injectable fluid from the syringe interior through thedistal needle interface.
 11. The method of claim 10, wherein the syringeassembly has: a transport configuration in which the swing spacer is inthe aligned configuration and a stop on the plunger member is disposed adistance proximal of a proximal surface of the swing spacer; a primedconfiguration in which the swing spacer is in the aligned configurationand the stop on the plunger member is in contact with the proximalsurface of the swing spacer; an injection configuration in which theswing spacer is in the askew configuration and the stop on the plungermember is disposed a distance proximal of with a proximal surface of thefinger flange; and a completed configuration in which the swing spaceris in the askew configuration and the stop on the plunger member is incontact with the proximal surface of the finger flange.
 12. The methodof claim 11, wherein the syringe assembly is provided in the transportconfiguration, the method further comprising: positioning the syringeassembly in the transport configuration in an upright orientation beforemoving the swing spacer from the aligned configuration to the askewconfiguration; and applying a distally directed force to the proximalend of the plunger member to expel a gas from the syringe interiorthrough the distal needle interface to transform the syringe assemblyfrom the transport configuration to the primed configuration beforemoving the swing spacer from the aligned configuration to the askewconfiguration, wherein moving the swing spacer from the alignedconfiguration to the askew configuration transforms the syringe assemblyfrom the primed configuration to the injection configuration, andwherein applying the distally directed force to the proximal end of theplunger member to expel the portion of the injectable fluid from thesyringe interior through the distal needle interface transforms thesyringe assembly from the injection configuration to the completedconfiguration.
 13. The method of claim 10, wherein the swing spacer inthe aligned configuration limits distal movement of the plunger memberrelative to the syringe body, and wherein the swing spacer in the askewconfiguration does not limit distal movement of the plunger memberrelative to the syringe body, such that the swing spacer is configuredto define a distance of movement of the plunger member relative to thesyringe body along the longitudinal axis of the syringe body, therebydefining a dose of the injectable fluid.
 14. The method of claim 10,wherein the two pairs of slots on the swing spacer comprises two alignedslots and two askew slots, wherein the aligned slots are configured tointerfere with the pair of bumps on the finger flange to removablyretain the swing spacer in the aligned configuration, and wherein theaskew slots are configured to interfere with the pair of bumps on thefinger flange to removably retain the swing spacer in the askewconfiguration.
 15. The method of claim 10, moving the swing spacer fromthe aligned configuration to the askew configuration comprises graspingthe pair of indentations on the swing spacer.